Kornimate/medical-research-clean huggingface dataset:
rnaseq analysis of microbial gene expression in necrotizing soft tissue infections

Conditions: Necrotizing Soft Tissue Infections

Summary: hypothesis: we hypothesize that rnaseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (nsti) and risk factors involved in acquiring these devastating infections tissue biopsies will be obtained from consented patients admitted with nsti. biopsies will be used for standard clinical analysis of bacterial species present or stored for later rna sequencing. rna sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the nsti site. medical charts will also be reviewed for basic patient information as well as wound care management practices. we hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to nsti's.


Eligibility criteria:
inclusion criteria: * patient or lar agrees to the procedure and signs informed consent form * patient is at least 18 yrs of age * patient has been diagnosed with an nsti exclusion criteria: * patient not willing to undergo additional tissue biopsies for rna sequencing analysis
pemetrexed in patients with chemosensitive and chemoresistant relapsed small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: patients with relapsed or chemotherapy-refractory sclc have a dismal prognosis. unfortunately, available treatments result in few durable responses. pemetrexed is a well-tolerated agent, which is active in nsclc. since chemotherapy agents, which are active in nsclc, are usually also active in sclc, this trial will examine the efficacy and activity of pemetrexed in this palliative setting

outline: this is a multi-center study. * pemetrexed 500 mg/m2 i.v. q 3 wks all patients will also receive folic acid 350-1000 mcg. po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, vitamin b12 1000 mcg. im every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, and dexamethasone 4 mg po bid the day before, the day of, and the day following each treatment with pemetrexed chest x-ray will be performed prior to each cycle (if other disease assessment by imaging is not performed) in order to ensure patients are not rapidly progressing. cycles are repeated every 3 weeks for up to 6 cycles or pd or intolerable side effects. performance status: ecog 0, 1, or 2 life expectancy: not specified hematopoietic: * wbc \> 3000/mm3 * anc \> 1500/mm3 * platelet count \> 100,000/mm3 * hemoglobin \> 8 g/dl hepatic: * bilirubin \< 1.0 x upper limit of normal * aspartate aminotransferase (ast, sgot) \< 2.5 x upper limit of normal. ast may be \< 5 x upper limit of normal for patients with liver metastasis renal: * creatinine clearance of \> 45 ml/ min (by cockcroft-gault) cardiovascular: * no unstable or uncompensated cardiovascular conditions pulmonary: * no unstable or uncompensated respiratory conditions

Eligibility criteria:
inclusion criteria: * histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site \[including lung\] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the recist criteria * chemoresistant or chemosensitive disease * patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent * radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to \< grade 1 or baseline prior to registration * negative pregnancy test exclusion criteria: * no clinically significant infections as judged by the treating investigator * no symptomatic cns metastasis * no radiation to \> 25% of the marrow containing spaces * no previous treatment with pemetrexed * no uncontrolled pleural effusions * no current breastfeeding
a study comparing atezolizumab (anti pd-l1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple-negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with stage ii-iii tnbc (triple negative breast cancer)


Eligibility criteria:
inclusion criteria: * non-metastatic operable stage ii-iii breast cancer * histologically documented tnbc (triple negative breast cancer) * confirmed tumor pd-l1 evaluation as documented through central testing of a representative tumor tissue specimen * adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy * adequate hematologic and end-organ function * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. * no more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization. * representative formalin-fixed, paraffin embedded (ffpe) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides. exclusion criteria * prior history of invasive breast cancer * for the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-her2 therapy. * previous therapy with anthracyclines or taxanes for any malignancy * cardiopulmonary dysfunction * prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * urinary outflow obstruction * active tuberculosis * major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab) * prior allogeneic stem cell or solid organ transplant * treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
de-escalation - antifungal treatment immunocompromised patients

Conditions: Invasive Fungal Disease; Critical Illness

Summary: a small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. however, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. moreover, empirical antifungal treatment is still a matter for debate in these patients. our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients. this prospective observational study is conducted in 14 icu, during a 6 months period. all immunocompromised patients hospitalized for \>5d and treated with antifungals for suspected or proven invasive candida infection will be included de-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. the three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin b.

this is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.

Eligibility criteria:
inclusion criteria: * adults immunocompromised patients hospitalized in intensive care units * predictable invasive mechanical ventilation duration \> 96h * signed consent (by patient or its representative) * first antifungal treatment initiation in icu for proven or suspected candida infection exclusion criteria: * pregnant or breast-feeding women. * fungal infection other than invasive candida * prophylactic antifungal treatment. * lack of informed consent * predictable mechanical ventilation duration less than 48 hours * patients discharged from icu before the 5th day after initiation of taf

Keywords: de-escalation antifungal treatment mortality immunocompromised intensive care
comparison of short-term sustained-release opioid in open abdominal urologic surgeries

Conditions: Pain, Acute; Opioid Use

Summary: the advantage of slow-release opioid allows for less fluctuation in drug (pain killer) levels in the blood and an extended period within the effective range for pain relief. the slow-release opioids have been preferred over the short-acting opioids because of the longer duration of action, which lessens the frequency and severity of end-of-dose pain. herein, the investigators propose the use of low dose slow-release opioid formulation offers better pain control in the first 48 hours post-operatively in open abdominal urologic surgeries.

this will be a randomized, double-blind, controlled trial looking at all adult patients undergoing open abdominal urologic surgeries. after assessing the inclusion/exclusion criteria, the patients will be randomized into one of two groups: group 1: sustained-release (long-acting) opioid on a regular basis for 2 days with immediate-release (short-acting) opioid available on an 'as required' basis group 2: immediate-release (short-acting) opioid on an 'as required' basis only. all patients will have a general anesthetic at the discretion of the anesthesiologist in the operating room and intravenous opioid will be administered in accordance with the anesthesiologists' discretion. pain score and analgesic consumption are the outcome measures.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing open abdominal urologic surgeries * asa 1-3 exclusion criteria: * patient refusal * history of chronic pain * allergy to hydromorphone * cannot swallow tablets

Keywords: postoperative pain opioid sustained-release opioid
woundchek™ protease status point of care (poc) diagnostic test on dfu

Conditions: Diabetic Foot Ulcers

Summary: the purpose of this trial is to determine if wounds with elevated protease activity (epa) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. it is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on epa wounds over current standard of care.


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years old * patients with a diabetic foot ulcer as defined by wagner grade 1 - 2 * abpi of ≥0.6 to ensure ischemia will not impact healing * no restriction on wound size or wound location * duration of ulcer ≥ 6 weeks ≤ 2 years * the patient must be able to understand the trial and provide written informed consent * no local or systemic signs of infection, with normal crp and leukocyte levels below 10 000 * wound has not been treated with promogran® in 4 weeks prior to inclusion exclusion criteria: * wound duration of less than 6 weeks or longer than 2 years * known hypersensitivity to any of the wound dressing used in the trial * current local or systemic antibiotics in the week prior to inclusion * patients with significant ischemia as defined by abpi of ≤0.6 * clinical infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema. * progressive neoplastic lesion treated by radiotherapy or chemotherapy * prolonged treatment with immunosuppressive agents or high dose corticosteroids * patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse) * patients with renal insufficiency (with egfr values \<30 or on rrt) life expectancy of \<6 months * patients with uncontrolled diabetes as determined by hb-a1c ≥ 12% ( = hb-1cifcc ≥ 107.65 mmol/mol) * patients who have participated in a clinical trial on wound healing within the past month * patients who are unable to understand the aims and objectives of the trial * patients with a known history of non adherence with medical treatment * females who are pregnant * subject has acquired immunodeficiency syndrome (aids) or is known to be infected with human immunodeficiency virus (hiv) * subject has viral hepatitis
frequency and impact of iron deficiency in pain clinic patients

Conditions: Iron Deficiency; Fibromyalgia

Summary: the goal of this study is to measure the proportion of patients who have iron deficiency and if iron deficiency is treated what is the outcome. this will be done by testing ferritin and hemoglobin levels of female patients at the degroote pain clinic and administering the appropriate iron supplementation treatment (oral/infusion) if necessary. participants will fill out a questionnaire to assess positive impact of iron supplementation treatment.

the study is an observational clinical audit, with an unblinded clinical intervention. iron deficiency and some chronic pain syndromes like fibromyalgia are more common in women of reproductive age. iron deficiency can present with symptoms that are similar to those of fibromyalgia, but once recognized, iron deficiency is typically easily treated. we intend to poll patients at the degroote pain clinic based on information from studies conducted in australia and great britain. we will determine who is at risk for iron deficiency based upon symptoms such as heavy periods, history of pregnancy, blood donation, diet, and any previous iron deficiency. we will then confirm the results with lab testing, and provide treatment if necessary. our goal is to find out the percentage of women with chronic pain who also have iron deficiency, and assess the effect of treating iron deficiency on their pain symptoms.

Eligibility criteria:
inclusion criteria: * patient at the degroote pain clinic * menstruating women between the ages of 18-49 * willingness to complete the questionnaire, and undergo laboratory tests if indicated. exclusion criteria: * the only exclusion criteria is unwillingness to participate

Keywords: iron deficiency fibromyalgia iron infusion therapy chronic pain
glycaemic index determination in oral nutrition supplements

Conditions: Glucose Metabolism Disorders

Summary: the glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. this property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with diabetes mellitus. the objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response.

the determination of the glycemic index will be conducted following the protocol described in the international standard organization 26642. specifically, the glycemic response of each food will be determined in 15 healthy volunteers, using a glucose-containing beverage with 25 g of glucose in 200 ml as a control for glycemic response measurement. the amount of food each volunteer will test will be equivalent to an intake of 25 g of digestible carbohydrates in a single intake. subsequently, increases in blood glucose levels will be recorded at 15, 30, 45, 60, 90, and 120 minutes after initiating the food intake. blood glucose measurements will be performed using a portable glucometer via capillary blood. the area under the curve of the increase in glucemia will be estimated using the trapezoidal method, and these will be compared with the glucose increases provided by the glucose-containing beverage.

Eligibility criteria:
inclusion criteria: • healthy volunteers with no known food allergy or intolerance and pharmacological treatments known to affect glucose tolerance (excluding oral contraceptives) exclusion criteria: * known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions. * any acute, chronic disease or any other serious complications that may interfere with glucose metabolism. * subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption. * subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion * a major medical or surgical event requiring hospitalization within the preceding 3 months. * pregnancy

Keywords: glycemic index glucose post-prandial digestible carbohydrates
pulmonary vascular impairment in chronic obstructive pulmonary disease (copd) assessed by mri

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: chronic obstructive pulmonary disease (copd) is a highly prevalent pulmonary disease providing major morbidity and mortality. bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known. improving knowledge on pulmonary vascular adaptive skills in copd patients could allow for better understanding disease exacerbations, evolution towards chronic pulmonary hypertension (ph) and therapeutics to be offered to the patients. magnetic resonance imaging (mri) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. this work aims at identifying pulmonary vascular impairment in copd patients using functional mri.

chronic obstructive pulmonary disease (copd) is a highly prevalent pulmonary disease providing major morbidity and mortality. bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known. however, it has been shown that emphysema, frequently observed in copd, contains major vascular lesions. alteration of pulmonary vascularisation have been found during exacerbation of the disease. moreover, it is well established that such vascular lesions form the substrate for endothelial dysfunction, expressed as an impairment of vascular adaptation during exercise, and evolving towards chronic pulmonary hypertension (ph). owing to its severe effects on the right-sided heart, it signs a pejorative turn in patients' survival and quality of life. finally, copd patients' phenotypes are very heterogeneous and the clinical response to ph treatments is variable; while some get a benefit, others are counter-indicated due to adverse effects. improving knowledge on pulmonary vascular adaptive skills in copd patients could allow for better understanding disease exacerbations, evolution towards ph and therapeutics to be offered to the patients. this area of research remains widely unknown because of the lack of simple tools to assess pulmonary vascularisation which could be used in clinical routine. magnetic resonance imaging (mri) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. this work aims at identifying pulmonary vascular impairment in copd patients using functional mri.

Eligibility criteria:
inclusion criteria: * age 40-70 * diagnosed with copd * emphysema on chest ct * fev1 between 35 and 80 % * screened for ph by echocardiography exclusion criteria: * side effect for exercise * side effect for mri and contrast agent injection * pregnancy or breastfeeding * refusing to be informed of the discovery of an anomaly on chest mri
hemostatic powder following injection therapy versus conventional dual therapy for endoscopic hemostasis for non-variceal upper gastrointestinal bleeding

Conditions: Upper Gastrointestinal Bleeding

Summary: acute upper gastrointestinal hemorrhage (ugih) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. the most common causes of acute ugih are nonvariceal. although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years. endoclot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. this study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. this is a multicenter, prospective, randomized study.

patients with upper gi bleeding who need endoscopic hemostasis will be enrolled in this study. when there is a upper gi bleeding with active bleeding or stigmata on the lesions, endoscopic hemostasis will be done. after randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. in the study group, endo-clot will be applied after epinephrine injection therapy. in the control group, hemoclip will be applied after epinephrine injection therapy. the efficacy of endo-clot and hemoclip will be compared.

Eligibility criteria:
inclusion criteria: 1. older than 19 years old 2. patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding 3. inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding 4. patients who are planned to undergo egd for management of upper gastrointestinal bleeding exclusion criteria: 1. patients who had diagnosed esophageal cancer or stomach cancer 2. patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma 3. coagulation disorder (hemophilia, itp,,) 4. post-procedure bleeding (egd biopsy, emr, esd, stent insertion..) 5. patients who cannot undergo egd because of anatomical problem, unconsciousness. 6. patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism

Keywords: upper gastrointestinal bleeding endoscopic hemostasis hemostatic powder